A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for avatrombopag

Abstract

Abstract Avatrombopag is a next-generation thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in patients with chronic liver disease scheduled to undergo surgery and thrombocytopenia in patients with chronic immune thrombocytopenia. However, realistic data on its post-marketing long-term safety and tolerability in large sample populations are incomplete. The adverse event (AE) reports of avatrombopag were analyzed based on the FAERS database. By extracting large-scale data from the FAERS database, this study used various signal quantification techniques such as reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker to calculate and evaluate the ratio and association between avatrombopag and specific AEs. In the FAERS database, data from the second quarter of 2018 to the fourth quarter of 2023 were extracted for this study, a total of 1217 avatrombopag-related AEs reports were included for analysis. Based on four calculation methods, this study identified and 32 preferred terms associated with avatrombopag. Common AEs in the product label such as thrombosis, headache, contusion, petechiae, and gingival bleeding were detected. AEs not mentioned in the product label, such as photopsia and ear discomfort were also detected. The first 30 days after initiation of medication were the most common period for both serious and non-serious AEs. This study demonstrates the common AEs and the potential AEs associated with avatrombopag in real-world practice, which could provide valuable cautionary evidence for clinicians and pharmacists to manage safety issues with avatrombopag.

Keywords

• Avatrombopag 
• FAERS 
• Adverse event 
• Thrombocytopenia 
• Chronic liver disease